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    Summary
    EudraCT Number:2015-002758-11
    Sponsor's Protocol Code Number:D4420C00005
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-08-06
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedLithuania - SMCA
    A.2EudraCT number2015-002758-11
    A.3Full title of the trial
    A Phase 2b Randomized, Double-blind Study to Evaluate the Efficacy of MEDI7510 for the Prevention of Acute Respiratory Syncytial Virus-associated Respiratory Illness in Older Adults
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy of MEDI7510 in Older Adults
    A.3.2Name or abbreviated title of the trial where available
    A Study to Evaluate the Efficacy of MEDI7510 in Older Adults
    A.4.1Sponsor's protocol code numberD4420C00005
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02508194
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMedImmune, LLC
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMedImmune, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedImmune, LLC
    B.5.2Functional name of contact pointClinical Trial Enquiries
    B.5.3 Address:
    B.5.3.1Street AddressOne Medimmune Way
    B.5.3.2Town/ cityGaithersburg, Maryland
    B.5.3.3Post code20878
    B.5.3.4CountryUnited States
    B.5.4Telephone number001301398 0000
    B.5.6E-mailclinicaltrialenquiries@medimmune.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMEDI7510
    D.3.2Product code MEDI7510
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN ---
    D.3.9.1CAS number *MASKED*
    D.3.9.2Current sponsor codeMEDI7510
    D.3.9.3Other descriptive nameRSV F SUBUNIT DRUG SUBSTANCE
    D.3.9.4EV Substance CodeSUB168542
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.36
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevention of Acute Respiratory Syncytial Virus-associated Respiratory Illness
    E.1.1.1Medical condition in easily understood language
    Prevention of RSV Illness
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10061603
    E.1.2Term Respiratory syncytial virus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of a single IM dose of MEDI7510 for the prevention of acute respiratory syncytial virus-associated respiratory illness (ARA-RI) in adults ≥ 60 years of age in Season 1 of dosing.
    E.2.2Secondary objectives of the trial
    1. To assess the safety and tolerability of MEDI7510 in Season 1 and Season 2
    2. To assess the incidence of RSV polymerase chain reaction (PCR)-positive respiratory
    illness in Season 1
    3. To assess the immunogenicity of inactivated influenza vaccine (IIV) administered alone
    as compared to administered concurrently with MEDI7510 in Season 1
    4. To assess the immune response to MEDI7510 in Season 1 and Season 2
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Season 1
    1. Age ≥ 60 years at the time of screening.
    2. Written informed consent and any locally required authorization (eg, Health Insurance
    Portability and Accountability Act) obtained from the subject prior to performing any
    protocol-related procedures, including screening evaluations.
    3. Medically stable such that, according to the judgment of the investigator, hospitalization
    within the study period is not anticipated and the subject appears likely to be able to
    remain in follow-up through the end of protocol-specified follow-up.
    4. Subject able to visit the clinic for study-specified visits and subject also available by
    telephone.
    5. Subject able to understand and comply with the requirements of the protocol.
    6. Subject able to complete study follow-up period in Season 1 and, according to investigator judgment, reasonably likely to complete the study follow-up period in Season 2 if assigned.

    Season 2
    1. Subject received MEDI7510 + IIV in the Northern Hemisphere in Season 1.
    2. Subject able to visit the clinic for study-specified visits and subject also available by
    telephone.
    3. Subject able to understand and comply with the requirements of the protocol.
    E.4Principal exclusion criteria
    Season 1
    1. History of allergy to any component of the vaccine.
    2. Receipt of seasonal influenza vaccine within 6 months prior to Season 1 dosing.
    3. History of allergy to or intolerance of IIV.
    4. Pregnancy or potential to become pregnant during the study.
    5. History of Guillain-Barré syndrome.
    6. Cognitive disorder such that informed consent cannot be obtained directly from the
    subject.
    7. Previous vaccination against RSV.
    8. History of allergy to eggs in adulthood.
    9. History of or current autoimmune disorder, with the exception of stable, treated hypothyroidism caused by autoimmune thyroiditis.
    10. Immunosuppression caused by disease, including human immunodeficiency virus
    infection (assessed by history), or medications. Any receipt of oral or intravenous
    glucocorticoid therapy within 30 days prior to enrollment or planned dosing within the
    follow-up period would disqualify. Topical, intranasal, inhaled, or intra-articular
    corticosteroids do not disqualify. Expected need for immunosuppressive medications
    during the follow-up period would disqualify.
    11. History of cancer within preceding 5 years other than treated non-melanoma skin cancer,
    locally-treated cervical cancer or in situ carcinoma of the breast.
    12. Significant infection or other acute illness, including fever ≥ 100°F (≥ 37.8°C) on the day
    prior to or day of randomization.
    13. Receipt of any non-study vaccine within 28 days prior to study dosing or expected receipt
    of non-study vaccine prior to the Day 29 visit in Season 1.
    14. Receipt of any investigational product in the 90 days prior to randomization or expected
    receipt of investigational product during the period of study follow-up.
    15. Receipt of immunoglobulins or blood products within 4 months of study dosing
    (120 days) or expected receipt of immunoglobulins or blood products during the period
    of study follow-up.
    16. Current bleeding or clotting disorder including use of anticoagulants other than drugs
    with anti-platelet activity (such as nonsteroidal anti-inflammatory drugs, clopidogrel,
    ticagrelor or aspirin).
    17. Any condition that, in the opinion of the investigator, would interfere with evaluation of
    the investigational product or interpretation of subject safety or study results.
    18. History of alcohol or drug abuse or psychiatric disorder that, in the opinion of the
    investigator, would affect the subject’s safety or compliance with study.

    Season 2
    1. Related Grade 3 or 4 AE including Grade 3 or 4 local reaction to either MEDI7510 or
    IIV, any AESI for an adjuvanted vaccine, or any related SAE.
    E.5 End points
    E.5.1Primary end point(s)
    The incidence of the first episode of ARA-RI observed during the RSV surveillance period in
    Season 1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At least 14 days after vaccination and during the RSV surveillance period.
    E.5.2Secondary end point(s)
    - The occurrence of all solicited symptoms (whether or not treatment-emergent) and
    treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events
    (TESAEs), new onset chronic diseases (NOCDs), and treatment-emergent adverse events
    of special interest (TEAESIs) in Seasons 1 and 2
    - The incidence of RSV PCR-positive respiratory illness during the RSV surveillance
    period in Season 1
    - The post-dose geometric mean titers (GMTs) and geometric mean fold rises (GMFRs)
    from baseline of strain-specific hemagglutination inhibition (HAI) antibodies to influenza
    antigens contained in the seasonal influenza vaccine received by subjects in the IIV
    immunogenicity subset; in addition, the proportion of subjects in the IIV immunogenicity
    subset who had a by-strain post-dose seroresponse to HAI antibody, defined as ≥ 4-fold
    rise from baseline
    - The immune response to MEDI7510 in Seasons 1 and 2 in subjects in the RSV
    immunogenicity subset
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Solicited symptoms: Day 1 through Day 7 Seasons 1 and 2
    - TEAE/TESAE/NOCD/TEAESIs: Day 1 through final Season 1 contact and/or Last Contact Season 2
    - Incidence of RSV-PCR positive respiratory illness: At least 14 days after vaccination and during the RSV surveillance period.
    - HAI: Day 29 Season 1
    - Immune response: Dosing through Last Contact Season 2
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Locally approved and marketed Inactivated Influenza Vaccine (IIV) administered per label
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Chile
    Estonia
    Latvia
    Lithuania
    South Africa
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    End of trial is last subject last visit in Season 2
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 570
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1330
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Adults 60 years of age and older, healthy or with stable chronic illness
    F.4 Planned number of subjects to be included
    F.4.1In the member state41
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 126
    F.4.2.2In the whole clinical trial 1900
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-11-07
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